MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAGEN? EL ICD VR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)

Model Number	D150
Medical Device Problem Code	Pacing Problem (1439)
Health Effect - Clinical Code	Bradycardia (1751)
Date of Event	06/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device remains in service.If pertinent information is provided in the future, a supplemental report will be submitted.
Event or Problem Description
It was reported that the health care professional (hcp) requested a review of reports for this implantable cardioverter defibrillator (icd).The hcp noted the icd exhibited pacing inhibition and had questions regarding the therapy delivered after.Technical services (ts) reviewed the data and noted the episode showed a fast onset of possible supraventricular tachycardia (svt) which accelerated into the ventricular fibrillation (vf) zone.Ts discussed quick convert was delivered and successfully terminated the arrhythmia.No adverse patient effects were reported.This icd remains in service.

• Brand Name: DYNAGEN? EL ICD VR
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 25654081
• Report Number: 2124215-2026-34535
• Device Sequence Number: 14922055
• Product Code: LWS
• UDI-Device Identifier: 00802526534287
• UDI-Public: (01)00802526534287(17)210509
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/09/2021
• Device Model Number: D150
• Device Catalogue Number: D150
• Device Lot Number: 253290
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2026
• Initial Report FDA Received Date: 06/29/2026
• Date Device Manufactured: 05/15/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Sex: Male